Coronary Artery Disease Clinical Trial
Official title:
Effectiveness of Text Messaging on Risk Factors Control and Medication Adherence Among Patients With Coronary Heart Disease and Diabetes in China: Cardiovascular Health and Text Messaging-Diabetes Mellitus (CHAT-DM) Study
The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention, including lifestyles modification, medication adherence improvement and risk factors control among coronary heart disease (CHD) patients with diabetes. The participants will be randomized into intervention and control groups in a 1:1 ratio. The intervention group will receive 6 pre-designed text messages per week in addition to usual care for 6 months, while the control group will receive usual care.
Objective: This study aims to evaluate the effectiveness of automated mobile phone text
message-based intervention for secondary prevention, including lifestyles modification,
medication adherence improvement and risk factors control among CHD patients with diabetes.
We hypothesized that an intervention using mobile phone text based education and reminder can
improve risk factors control and medication adherence for CHD patients.
Study design: The study is a two-arm, parallel, randomized clinical trial. Patients will be
eligible if they have documented CHD defined as having history of myocardial infarction and
percutaneous coronary intervention (PCI), have a history of diabetes mellitus, have the
capability of reading and sending short message, and are able to provide informed consent.
Patients will be excluded if they do not have an active mobile phone. The eligible
participants will be allocated into intervention and control groups in a 1:1 ratio randomly.
The intervention group will receive intervention of pre-designed text messages in addition to
usual care, while the control group will receive usual care. All the participants will be
followed up for 6 months.
Study intervention: Participants in the intervention group will receive text messages for 6
months as well as usual care. They will receive one general messages, one hypertension
message, one glucose control message, one lifestyle message, one medication adherence message
and one physical activity message per week.
Outcome measures: The primary endpoint is the change in glycemic hemoglobin (HbA1C) as
measured by central blood sample. Secondary endpoints include a change in proportion of
patients achieving HbA1C<7%, body mass index (BMI), physical activity, medication adherence,
systolic blood pressure, low-density lipoprotein cholesterol (LDL-C) and fasting blood
glucose (FBG). Exploratory endpoints include long-term prognosis of the patients, such as
death, nonfatal myocardial infarction, stroke and so on, as well as health status (SAQ and
EQ-5D).
Statistical analysis: Evaluation will be carried out on an intention-to-treat basis. Values
of analyzed endpoints between intervention group and control group will be compared according
to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be
conducted accordingly.
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